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Recruiting NCT06149585

Changes in Microbial Status From Dentate, Edentulous and After Dental Implant Placement

Trial Parameters

Condition Edentulous Mouth
Sponsor Case Western Reserve University
Study Type OBSERVATIONAL
Phase N/A
Enrollment 12
Sex ALL
Min Age 21 Years
Max Age N/A
Start Date 2023-08-16
Completion 2026-05-01
Interventions
Microbial Sampling

Brief Summary

The objectives of this study are to analyze the oral microbiome modulations occurring during the transition from partial (with some residual teeth) to full edentulous (without remaining teeth) status and implant placement in subjects affected by severe periodontitis; to evaluate if microbiome changes in relation to the used of different implant material/surface; and to assess the variance of the changes to determine the sample size for future longitudinal prospective studies.

Eligibility Criteria

Inclusion Criteria: 1. At least 21 years of age 2. Diagnosis of Stage III or IV periodontitis based on full mouth probing and full mouth x-rays 3. Planned for full mouth extraction and replacement by dental implants. 4. Rehabilitation with Implant supported restorations either maxilla and/ or mandible. 5. At least 2 implants available for examination. 6. No bone augmentation required. Exclusion Criteria: 1. Conditions requiring chronic routine prophylactic use of antibiotics. 2. Conditions requiring prolonged use of steroids. 3. History of leukocyte dysfunction and deficiencies 4. Bleeding disorders 5. History of neoplastic disease requiring use of radiation or chemotherapy 6. Metabolic bone disorders 7. Uncontrolled endocrine disorder 8. Use of any investigational drug or device within the 30 day period prior to implant surgery. 10\. Alcoholism or drug abuse 11. Patient infected with HIV 12. Condition or circumstances, in the opinion of the investigator, which would prevent completion

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